FDA Declares New 'Designer Steroid' Illegal
Posted: 2:09 p.m. PST October 28, 2003Updated: 2:17 p.m. PST October 28, 2003
The Food and Drug Administration today announced that a recently
discovered so-called "undetectable steroid" is an illegal drug, not a
dietary supplement.
As a result, the substance known as tetrahydrogestrinone, or THG,
cannot be legally marketed without FDA approval under the agency's rigorous
approval standards that are meant to ensure that drugs sold to Americans are
safe and effective.
The decision comes after last week's U.S. Anti-Doping Agency
investigation into a Burlingame-based laboratory that was identified as an
alleged source of THG.
Today, FDA officials said they are concerned about the marketing
and use of the unapproved product and the agency is working with other
federal law enforcement agencies to aggressively "engage, enforce and
prosecute those firms or individuals who manufacture, distribute or market
THG."
This could include Burlingame's BALCO Labs. Several high-profile
Bay Area athletes, including Giants slugger Barry Bonds, have been called
upon to testify in the case against BALCO.
"Our mission is to protect the American public from this
potentially harmful product," said FDA Associate Commissioner for Regulatory
Affairs John Taylor.
In the meantime, the FDA is warning consumers that while little is
known about the safety of the drug, its structure and relationship to better
known products had led the agency to believe that its use may pose
considerable risks to individuals' health.
FDA officials say that while suppliers of THG may represent it as
a dietary supplement, it doesn't meet the dietary supplement definition.
Instead, they say, it is a purely synthetic "designer" steroid derived by
chemical modification from another anabolic steroid that is explicitly banned
by the U.S. Anti-Doping Agency.
Federal health officials are warning users of the substance's
potential health effects because of its close structural relationship to
anabolic steroids, which have been known to not only build muscle mass, but
also to cause serious, long-term health consequences in men, women and
children, including liver damage, heart disease and anxiety.
Copyright 2003 by Bay City News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.











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